Real-world Evidence Study EvaLuating PAtient-Reported Outcomes With XERMELO (RELAX)

TerSera Therapeutics

Status: Completed

Conditions: Carcinoid Syndrome

Treatments: Drug: Xermelo

Study type: Observational

Funder types: Industry

Identifiers

NCT03223428

LX1606.401 (Other Identifier)

LX1606.1-401-CS

Details and patient eligibility

About

The primary objective of the study is to estimate the proportion of carcinoid syndrome (CS) patients who are satisfied with their overall symptom control, 6 months after initiating treatment with telotristat ethyl (XERMELO).

Full description

This study will evaluate patient-reported outcomes for adults initiating telotristat ethyl (XERMELO) for carcinoid syndrome diarrhea (CSD) not adequately controlled by somatostatin analogs in US clinical practice. The primary objective is satisfaction with overall CS symptom control 6 months after starting XERMELO. Secondary objectives will evaluate satisfaction with control of CSD and flushing, CS symptoms, work productivity and activity impairment, SSA use, and weight. This study will provide real-world patient-reported outcomes in CS with XERMELO treatment for at least 6 months.

Enrollment: 223 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult, ≥18 years of age at the time of informed consent
• A new, valid prescription for XERMELO
• Initiating XERMELO for the treatment of carcinoid syndrome
• Able and willing to provide informed consent prior to participation in the study

Exclusion criteria

• Unable to understand and read English
• Unable to access the internet
• Prior exposure to XERMELO

Trial design

223 participants in 1 patient group

Carcinoid Syndrome patients initiating Xermelo

Description:

Patients with Carcinoid Syndrome who are initiating treatment with XERMELO.

Treatment:

Drug: Xermelo